Median Technologies Partners With Leading U.S. Healthcare Company to Bring eyonis® LCS to Patients Across the U.S. and Europe

• Non-exclusive commercial agreement for the distribution of eyonis^® LCS in the United States and Europe
• The agreement will become effective upon FDA 510(k) clearance
• Partner’s robust infrastructure and broad market reach in both the U.S. and Europe will maximize commercial launch

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, “Median” or the “Company”), manufacturer of eyonis^® , a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced the signing of a non-exclusive global commercial distribution agreement with a leading US healthcare company. The agreement covers the future commercialization of eyonis^® LCS, Median’s AI-based SaMD for lung cancer.

The collaboration will leverage the commercial partner’s robust infrastructure and broad market reach in both the U.S. and Europe to ensure efficient distribution of eyonis^® LCS, once regulatory clearances are granted in the U.S., then in Europe. Both companies will collaborate closely in a structured and coordinated manner to ensure a strong impact following 510(k) clearance. The commercial phase of this collaboration is expected to begin once Median Technologies will have obtained 510(k) clearance for eyonis^® LCS from the US FDA, which is anticipated in early Q1 2026. eyonis^® LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet for sale in the US and in Europe.

“This strategic, non-exclusive collaboration with a recognized healthcare leader, will position us for a successful commercial rollout of our eyonis^® LCS Software as a Medical Device and long-term impact,” said Fredrik Brag, CEO and Founder of Median Technologies. “This agreement, which comes as we approach key regulatory milestones with upcoming decisions on approval in the U.S. and Europe, strengthens our ability to accelerate the deployment of lung cancer screening. It also enhances our capacity to further improve patient outcomes, by supporting public health initiatives aimed at reducing lung cancer mortality through screening”.

About eyonis^® LCS: eyonis^® Lung Cancer Screening (LCS) is an AI-based computer aided detection and diagnosis (CADe/CADx) Software as a Medical Device (SaMD) that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to aid radiologists in diagnosis of lung cancer at the earliest stages. eyonis^® LCS has been the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (Clinicaltrials.gov ID: NCT06576232) and RELIVE (Clinicaltrials.gov ID: NCT06751576), both of which have been successfully completed. Based on these pivotal data, Median Technologies submitted U.S. application for 510(k) clearance of eyonis^® LCS on May 13th, 2025, and European application for CE mark on June 30th, 2025. eyonis^® LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet for sale in the US and in Europe.

About lung cancer screening in the U.S.: Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history and covered by Medicare; the eligible population is currently of 14.5 million people. There already is an existing reimbursement of $650 per SaMD procedure creating a substantial commercial opportunity to improve patient care in this addressable market. Furthermore, the eligible patient number is expected to rise in the coming years, driven by planned broadening of the eligible U.S. population by USPSTF. Similarly, new lung screening program deployments are planned in Europe and Asia.

About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis^® , an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com.

Disclaimer

eyonis^® LCS is pending 510(k) clearance and CE marking is not yet available for sale in the United States and in Europe.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.

These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

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